MK-8294MK-8294MK-8294MK-8294MK-8294MK-8294MK-8294MK-8294CD8 PET Tracer
MK-8294: 30 µg via intravenous (IV) infusion
MK-8294: 100 µg via intravenous (IV) infusion
MK-8294: 300 µg via intravenous (IV) infusion
MK-8294: 1 mg via intravenous (IV) infusion
MK-8294: 3 mg via intravenous (IV) infusion
MK-8294: 10 mg via intravenous (IV) infusion
MK-8294: 30 mg via intravenous (IV) infusion
MK-8294: 70 mg via intravenous (IV) infusion
CD8 PET Tracer: IV Infusion
Study summary
MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor \[ER\]/progesterone receptor +, human epidermal growth factor receptor 2 negative \[HER2-\]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has a history of New York Heart Association Class II or greater heart failure
* Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
* Has ongoing radiation-related toxicities, requiring corticosteroids
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
* Has active infection requiring systemic therapy
* Has history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or have ongoing surgical complications
Primary outcome measure(s)
Number of participants who experience one or more dose-limiting toxicities (DLTs) — Up to approximately 35 days DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period (up to 35 days) that results in a change to a given dose or a delay in initiating the next treatment and reported as the number of participants experiencing a DLT.
Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 2 years An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 2 years An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study/study treatment due to an AE will be reported.
Trial sites (7)
Facility
City
Region
Status
Northwestern University ( Site 0101)
Chicago
Illinois
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0105)
Hackensack
New Jersey
Recruiting
Houston Methodist Hospital ( Site 0103)
Houston
Texas
Recruiting
Rambam Health Care Campus ( Site 0201)
Haifa
Israel
Recruiting
Sheba Medical Center ( Site 0200)
Ramat Gan
Israel
Recruiting
Radboudumc ( Site 0301)
Nijmegen
Gelderland
Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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